Kornimate/medical-research-clean huggingface dataset:
the rolex registry (revascularization of left main with resolute onyx)

Conditions: Coronary Artery Disease

Summary: the primary objective of this study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent resolute onyx in the treatment of unprotected left main coronary artery disease (ulmcad), both isolated or in association with two- or three-vessel coronary artery disease.

the rolex study is a prospective, non-randomized, european, multi-center registry. four hundred and fifty patients with unprotected left main coronary artery disease (ulmcad) will be enrolled at up to 40 european sites. the main objective of the study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent resolute onyx in the treatment of ulmcad, both isolated or in association with two- or three-vessel coronary artery disease

Eligibility criteria:
inclusion criteria: * subject \> 18 years old * ulmcad with angiographic diameter stenosis \>50% (if 50-70% evidence of ffr \<0.80 or ivus minimal lumen area \<6.0 mm2 is recommended. * silent ischemia, stable angina, unstable angina or non-st elevation myocardial infarction * ability to provide written informed consent and comply with follow-up for at least 2 years. exclusion criteria: 1. clinical exclusion criteria: * prior pci on the left main trunk or prior cabg. * concomitant indication to cardiac surgery (severe heart valve disease etc.) * cardiogenic shock (killip\>2) * severe renal insufficiency (gfr \<30 ml/min) * known impaired left ventricular function (left ventricular ejection fraction \<30%) * inability to tolerate or comply with dual antiplatelet therapy for at least 1 year * pregnancy or intention to become pregnant * life expectancy less than 1 year * other investigational drug or device studies that have not reached their primary endpoint 2. angiographic exclusion criteria: * left main diameter stenosis \<50% * syntax score \>33
virtual ileostomy versus diverting ileostomy in patients undergoing total mesorectal excision

Conditions: Rectal Cancer

Summary: the goal of this clinical trial is to learn to compare the safety and efficacy of virtual ileostomy versus diverting ileostomy in patients undergoing sphincter-saving surgery for rectal cancer. the main questions it aims to answer are: * is the virtual ileostomy a safe and effective alternative to the ileostomy? * is it scientifically reasonable to perform diverting ileostomy intraoperatively? researchers will compare virtual ileostomy to diverting ileostomy to see if the virtual ileostomy works to reduce rates of stoma. participants will: * performing diverting ileostomy or virtual ileostomy undergoing sphincter-saving surgery for rectal cancer * continuous follow-up of their complications after the first surgery

this study is a national multicenter, large-sample, randomized controlled study

Eligibility criteria:
inclusion criteria: * diagnosis of rectal cancer confirmed by pathology * age ≥ 18 years * total mesorectal excision (tme) surgical procedures and colon-rectum or colon-anal anastomosis：1.anterior resection (ar/ pme), 2. low anterior resection (lar) , 3.intersphincteric abdominoperineal resection (isr), 4.transanal total mesorectal excision (tatme) * signed informed consent * ability to understand the nature and risks of participating in the trial exclusion criteria: * emergency surgery, open surgery * asa score \>3points * patients with combined complete intestinal obstruction * long-term history of using immunosuppressants or glucocorticoids * combined severe cardiac disease: with congestive heart failure or nyha cardiac function ≥ grade 2. patients with a history of myocardial infarction or coronary artery surgery within 6 months before the procedure * chronic renal failure (requiring dialysis or glomerular filtration rate \<30 ml/min) * intraoperative combined multi-organ resection * combined cirrhosis of the liver * intraoperative findings of incomplete anastomosis and positive insufflation test * modified bacon procedure(two-stage turnbull-cutait pull-through coloanal anastomosis) * due to an intraoperative accident the surgeon felt that a diverting ileostomy was necessary. * currently participating in other clinical trials

Keywords: virtual ileostomy diverting ileostomy
long term results of 450 percutaneous closures of pda in a single center

Conditions: Patent Ductus Arteriosus

Summary: percutaneous closure is one of the methods used to treat, among other congenital heart disorder, persistent ductus arteriosus (pda) in children and adults. during the years 1998-2013 four hundred and fifty patients were catheterized in the department of pediatric cardiology and congenital heart diseases in rambam health care campus, using various devices. in this retrospective research, the investigators analyze data from patients' medical files, to estimate and define the correlation between the patients' demographic and morphologic data to the type and size of chosen closure device. aim of study: to create an algorithm that can be used to choose the proper device for percutaneous closure of the pda, based on the characteristics of the patient and the pda type.

the investigators analyze the demographic characteristics of patients before the procedure (age, gender, weight, height, co-morbidities etc.), the type and characteristics of pda and the chosen device, success and failure rates of the procedure, and adverse effects. the data is taken from patients' medical files - based on medical reports regarding physical examination, blood tests and imaging studies including cineangiograms and echo-doppler studies.

Eligibility criteria:
inclusion criteria: * all the patients that underwent percutaneous closure of pda between january 1998 and august 2013 in the department of pediatric cardiology and congenital heart diseases in rambam health care campus exclusion criteria: * none

Keywords: patent ductus arteriosus
endothelial monocyte-activating polypeptide-ii in egyptian sickle patients

Conditions: Sickle Cell Disease

Summary: this study objectives to assess the role of endothelial monocyte-activating polypeptide ii (emap ii) as a marker of endothelial dysfunction and disturbed angiogenesis in sickle cell disease and to identify its correlation with the oxidative status.

study design: screening/baselie phase * detailed medical history with special emphasis on demographic data, transfusion and chelation therapy, disease modifying therapy * thorough clinical examination * laboratory investigations to be done will include: * liver function test * marker of hemolysis * serum ferritin . * complete blood count(cbc) * hemoglobin electrophoresis * determination of serum levels of emap ii * lipid peroxidation (malondialdehyde concentration.), superoxide dismutase activity, catalase activity, glutathione peroxidase activity, glutathione reductase activity, vitamin e concentration, gsh the patients under investigations will receive vitamin e supplementation for three months patients will be followed up for clinical assessment lying stress on frequency and severity of sickling crisis, length of hospital admission, and frequency and severity of painful crisis the biochemical investigations, emapii and oxidative stress biomarkers will be measured also after the three months vitamin e oral administration. statistical analysis result will be expressed as the mean (+/-) standard deviation (sd). for all tests significance was set at p\<0.05. all statistical analysis will be performed using software package spss version 17.0 (spss inc,chicago, il, usa). differences over time will be tested with analysis covariance (anova) repeated measures. repeated measures analysis will be used to test treatment and time effects in addition to group -by- time interaction for clinical laboratory parameters. in cases where interactions will be identified, post hoc comparisons will be adjusted using bonferroni correlations.

Eligibility criteria:
inclusion criteria: * patients with sickle cell disease as confirmed by qualitative and quantitative analysis of hemoglobin using high performance liquid chromatography (hplc) at their steady state. exclusion criteria: * patients with any inflammatory condition within one month prior to enrollment.
whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees

Conditions: Amputation; Traumatic, Leg, Lower

Summary: this study will investigate the effects of whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees. this study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, and el wafaa wel amal hospital. all participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

the postural steadiness is the dynamics of the postural control system associated with maintaining balance during quiet standing and usually assessed by the displacement of the centre of pressure (cop). the control of posture is maintained by a complex sensory-motor system, which integrates information from the visual, proprioceptive, vestibular and somato-sensory systems. in the case of a unilateral trans femoral amputee, the individual becomes structurally asymmetrical, as there is an altered sensation and a loss of musculature on the amputated side. whole-body vibration (wbv) is a therapeutic method that exposes the entire body to mechanical oscillations while the patient stands or sits on a vibrating platform. this method was used in rehabilitation to improve muscle function, joint stability, balance control and to reduce the risk of falling. whole-body vibration (wbv) training helps to improve the dysfunction of the nervous system and musculoskeletal system diseases, to prevent and relieve osteoporosis in the elderly, and to promote sports injury recovery and improve sports performance. but till now there is no judgment concerning the difference and significance of whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees.

Eligibility criteria:
inclusion criteria: * 40 to 55 years of age. * residual femoral length from ischial tuberosity to the end of the limb with distal soft tissue compressed (15-35 cm) * unilateral trans-femoral traumatic amputation with single-axis mechanical knees, axial foot (single axis). * able to walk without the use of any assistive device; subjects must have obtained a score of \> 5 for houghton scale to indicate active use of prosthesis and \> 41 for berg balance scale (bbs). * medicare level 3 (community) ambulatory or above. * ability to descend stairs and hills without caregiver and assistive devices. * be able to independently provide informed consent. * be willing to comply with study procedures. exclusion criteria: * reduced somatosensory sensibility of the non-affected limb, ulceration or pain at the stump * the amputation was of vascular origin * poor fittings of prosthesis * visual or vestibular impairment (vertigo or dizziness) * lower limb musculoskeletal injury and other neurological deficits

Keywords: postural stability amputee
anlotinib-based combination therapy in patients with hormone receptor-positive（hr+） metastatic breast cancer(mbc) .

Conditions: HR+ Breast Cancer

Summary: cyclin-dependent kinases 4 and 6 (cdk4/6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (hr+), human epidermal growth factor receptor 2 (her-2)-negative metastatic breast cancer (mbc). however, the optimal treatment after progression on cdk4/6 inhibitors remains unknown. anlotinib is an oral multi-target tyrosine kinase inhibitor (tki) that strongly inhibits vegfr, pdgfr, fgfr, and c-kit. this study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with hr+ mbc previously treated with a cdk4/6 inhibitor.


Eligibility criteria:
inclusion criteria: * female patients aged 18 to 75 years, with an ecog score of 0-1, and an expected survival of at least 3 months; * presence of measurable lesions as defined by recist 1.1 criteria; * histopathologically confirmed hr-positive/her2-negative breast cancer. her2 negativity is determined by an immunohistochemistry (ihc) result of her2 (0/1+). if the result is her2 (++), a fish or cish test is required to confirm the absence of her2 amplification; * patients who have undergone multiple lines of advanced therapy with no remaining standard treatment options; * prior treatment with at least one line of cdk4/6 inhibitors and endocrine therapy; * disease progression following aromatase inhibitor (ai) or fulvestrant combined with cdk4/6 inhibitors, either as adjuvant therapy or as systemic treatment for advanced disease. exclusion criteria: * patients with her2-positive breast cancer confirmed by histology or cytology; * patients who discontinued therapy due to non-disease progression reasons, such as adverse events or other non-medical factors; * detection of a second primary malignant tumor at the time of enrollment; * failure to complete cdk4/6 inhibitor therapy; * pregnant or breastfeeding patients; * presence of third-space fluid accumulation (e.g., pleural effusion, ascites, pericardial effusion) that cannot be managed through drainage or other methods; * patients previously treated with anti-angiogenic agents, including small molecules such as anlotinib or apatinib, and large molecules such as bevacizumab; * patients currently receiving any other anti-tumor treatment for any other malignancies.
cold or hot snare endoscopic mucosal resection for 10-19mm non-pedunculated colorectal polyps

Conditions: Colorectal Polyp

Summary: this is a prospective, randomized, open-label, non-inferiority, multiple-center trial. outpatients who are scheduled to undergo colonoscopy and found eligible polyps will be randomized to receive either cold snare endoscopic mucosal resection (cs-emr) or hot snare endoscopic mucosal resection (hs-emr). this study aims to compare the efficacy and safety of cs-emr or hs-emr for the resection of non-pedunculated colorectal polyps sized 10-19mm.


Eligibility criteria:
inclusion criteria: * 18-80 years of age; * undergo colonoscopy in the digestive endoscopy center of peking union medical college hospital, beijing tsinghua changgung hospital or seventh medical center, general hospital of the chinese people's liberation army; * volunteer to participate in this study and sign informed consent; * at least one polyp sized 10-19 mm (paris classification is or iia) by colonoscopy. exclusion criteria: * american society of anesthesiologists (asa) status class 3 or above; * poor bowel preparation (boston bowel preparation scale \< 6 points); * known or endoscopic features indicating the submucous infiltration or malignancy; * oral anti-coagulants, or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency (platelets\ 1.5); * a history of colorectal resection; * emergency colonoscopy (hemodynamic instability and/or continued active gastrointestinal bleeding and/or requiring intensive care patients); * inflammatory bowel disease, familial polyposis, and colorectal cancer; * pregnancy or lactation; * severe cardiopulmonary dysfunction, liver cirrhosis, chronic kidney disease, other malignant tumors, or severe infectious diseases.
oral astaxanthin and semen quality, fertilization and embryo development in assisted reproduction techniques procedures

Conditions: Infertility, Male

Summary: the purpose of the study is to determine whether administration of dietary supplement of astaxanthin with vitamin e improves the quality of sperm, fertilization and embryo development in assisted reproduction techniques (art) procedures.

in the study male patients diagnosed with oligoasthenozoospermia - with an abnormal sperm concentration and motility, irrespective of the morphology of spermatozoa - treated with their female partner with assisted reproduction techniques (isci) will be included. in the double blind study male patients will be given astaxanthin with vitamin e (study group, 40 patients) or placebo (control group, 40 patients) for three months prior to art. in the study and the control group the quality of sperm (spermiogram), dna fragmentation and mitochondrial membrane potential of semen before and after the dietary supplementation will be evaluated. in the art procedure (icsi) the fertilization rate, the quality of embryos, pregnancy rates and miscarriages rates in 1st trimester will be compared between the study and control group.

Eligibility criteria:
inclusion criteria: * oligoasthenozoospermia with of without teratozoospermia by who criteria from the year 2010 * fresh semen * female partner younger than 38 years * idiopathic or tubal infertility in female partners * at least 4 oocytes retrieved in previous ovarian punction in art cycle, if previously performed * 1st, 2nd or 3rd cycle of art exclusion criteria: * genetic indication for art procedure * donated semen * polycystic ovary syndrome in female partner * dietary supplementation intake of antioxidants (selenium, zink, vitamin e, vitamin c, vitamin a) in male participant in the last three months * smoking in male participant \>20 cigarettes per day

Keywords: male infertility spermatogenesis antioxidants dna damage mitochondrial membrane potential apoptosis
high-speed resistance training program in independent older adults

Conditions: Old Age; Atrophy; Aging

Summary: the aims of the present investigation are: a) to determine the effects of a 16-weeks high-speed resistance training program on health parameters in independent older adults; and b) to verify the durability of the effects after 6 and 12 months after the intervention.

the present investigation will last a total of 18 months. more specifically, two weeks for initial assessments, then the 16-weeks training program. after that, there will be a 1-year follow-up. regarding the training program, it consists in a high-speed resistance training program of 16-weeks, with three sessions per week (mondays, wednesdays, and fridays) of 50-60min, each session being comprised of five-six exercises, two-three sets, and six-ten reps/exercise. the following exercises are used during the intervention period in pneumatic machines: incline bench press, squat in multipower or with dumbbell, leg extension, seated low row, leg press, calf raise, chest fly and lat pull down. the intensity is gradually increased after each session in accordance with the movement velocity (\>1.3 to 0.75 m/s) representing approximately 20% to 60% of one repetition maximum. participants execute the exercises rapidly and explosively making all repetitions for each shortening phase (concentric phase) performed as quickly as possible with the lengthening phase of the muscle (eccentric phase) being controlled for 2-3 s. the velocity of the concentric phase in each exercise is monitored through a beast™ sensor (beast technologies, brescia, italy). participants unavailable to participate in the intervention period will be allocated to the control group. these participants continue their usual activity without engaging in any resistance training or beginning a new exercise program during the study.

Eligibility criteria:
inclusion criteria: * participants of both genders; * aged 65 years old or more; * can walk and perform daily tasks independently and autonomously. exclusion criteria: * people with cognitive impairment; * people with neurodegenerative diseases; * people with diabetes disease; * people with heart/respiratory pathology or use of pacemakers; * people with musculoskeletal injuries in the 6 months before the study; * people with active oncology disease; * people with an uncontrolled hypertension (\>90 mmhg; \>150 mmhg); * people participate in other supervised exercise program; * paeople who refuse to sign the informed consent.

Keywords: aging older adults resistance training velocity-based training health outcomes phase angle gait variability
does intravenous cannabis reduce postoperative nausea and vomiting (ponv)?

Conditions: Nausea; Vomiting

Summary: the investigators evaluate if intravenously applied thc (cannabis) reduces postoperative nausea and vomiting. thc will be given during anesthesia before emergence. we measure how long and how effective it reduces ponv


Eligibility criteria:
inclusion criteria: * asa i-iii * elective open and laparoscopic surgery \>1hour exclusion criteria: * ambulatory surgery * pregnancy, breast feeding * \>asa iii * bmi \>35 * antipsychotic, antiemetic, cytostatic therapy * major cardiovascular, renal, hepatic, central nervous system disease * current chronic cannabis consumption and hard drug abuse * schizophrenia * preoperative nausea and vomiting, vestibular disease * not speaking german or french * refusal to participate

Keywords: anesthesia thc postoperative nausea
bifocal soft contact lenses and their effect on myopia progression in children and adolescents.

Conditions: Myopia; Esophoria; Fixation Disparity

Summary: the purpose of this study is to determine whether bifocal soft contact lenses are effective in controlling the progression of myopia in children and adolescents that exhibit a tendency to excessively cross their eyes while reading (esophoria or eso fixation disparity). several studies have demonstrated that bifocal or progressive multifocal spectacles are effective in slowing the progression of myopia in children either with near point esophoria and/or with inadequate focusing at near. a prominent theory for one cause of myopia progression is that poorly focused images on the back of the eye (retina) cause the eye to lengthen, causing an increase in myopia. bifocal contact lenses may reduce this retinal defocus, reducing the stimulus to eye elongation, and thus may reduce myopia progression.

myopia has become the focus of growing attention and concern because the prevalence of myopia appears to increasing in some populations (reaching 90% for some university student populations in asia). there are serious risks to higher levels of myopia, including cataracts, glaucoma, retinal detachment and myopic retinal degeneration. several studies have shown mild to moderate control of myopia progressionwith bifocal or multifocal spectacles in children with esophoria at near and/or with accommodative deficiencies. pilot studies by the p.i. have suggested that bifocal contact lenses may control myopia progression in children with near point eso fixation disparity. control is a controlled, randomized, prospective, double-blind, one year study of the changes in myopia in 80-90 subjects from age 8-18 with low to moderate levels of myopia, low levels of astigmatism, and eso fixation disparity at near, when fitted with either bifocal soft contact lenses or single vision soft contact lenses. the primary outcome measures will be cycloplegic refraction and axial length measures.

Eligibility criteria:
inclusion criteria: * myopia between -0.50 and -6.00 * eso fixation disparity at 33cm with distance correction * astigmatism 1.00 or less * ability to wear soft contact lenses exclusion criteria: * presence of ocular disease preventing wear of contacts * pregnancy or nursing * use of certain medications

Keywords: myopia progression myopia control bifocal contact lenses esophoria fixation disparity